Stimwave LLC, a leading innovator in wireless medical device technology
and independent research institute, has received FDA 510(k) clearance
for the first wireless, micro-technology neuromodulation device that can
enable ongoing full-body MRI scans under certain scanning conditions for
the relief of chronic peripheral nerve pain.

Representing a life-changing technological breakthrough for the more
than 400 million people worldwide who suffer from severe intractable
chronic pain, the StimQ Peripheral Nerve Stimulator (PNS) System offers
an alternative for those who do not want to rely on invasive surgical
procedures or ongoing opioid treatments. The smallest neuromodulation
device available, the StimQ device can be placed in a
minimally-invasive, outpatient procedure for the treatment of various
pain syndromes, including, but not limited to: shoulder pain, upper
extremity neuropathy, mid and lower back pain, and lower extremity
neuropathy. The new FDA clearance enables the pain sufferer to have
frequent and necessary MRI scans of any part of their body without
removing the implant.

"Thanks to our revolutionary wireless device, we are the only
neuromodulation company cleared by the FDA to help patients reduce their
chronic neuropathic pain by pinpointing stimulation directly to the
affected peripheral nerves with a multi-electrode programmable device,
which enables ongoing MRI scans," said Stimwave Chairman and CEO Laura
Tyler Perryman.

"This is great nes for many chronic pain patients who previously did
not have a minimally-invasive implant option available for peripheral
nerve-related pain and will continue to require frequent MRI scans
throughout their body for management of their pain and monitoring of
their current and future medical needs," said Dr. Konstantin Slavin,
professor of neurosurgery at University of Illinois at Chicago and
author of the book "Peripheral Nerve Stimulation." "While PNS has been
shown in literature to be an effective treatment, for many years device
placement has been difficult due to the bulk and length of cables,
connectors and pulse generators needed to stimulate a small nerve
target. This miniature wireless peripheral nerve stimulator that
minimizes the need for surgery in patients who are already suffering
from pain, while allowing on-going care with full body MRI scan
capabilities may provide a viable, non-opioid option for long-term pain
management."

The state-of-the-art device, which is less than five percent of the size
of other standard implanted options, provides pain relief by delivering
small pulses of energy in a fully-selectable manner to electrodes placed
at a peripheral nerve enabling the brain to remap specific pain signals.
The implant is powered by a small, flexible and comfortable wearable
external unit. The company previously received FDA clearance for the
Freedom-8A/4A Spinal Cord Stimulation (SCS (News - Alert)) System, which is also full
body MRI scan cleared and utilizes the same technology specifically for
back and leg pain based on placements in the spinal column region. Both
the Freedom SCS System and the StimQ PNS System are available now, and
more information can be found at www.stimwave.com.

About Stimwave LLC

Stimwave LLC is a privately held medical device company engaged in the
development, manufacture, and commercialization of wirelessly powered,
microtechnology neurostimulators, providing patients with a convenient,
safe, minimally invasive, and highly cost-effective pain management
solution that is easily incorporated into their daily lives. Stimwave's
goal is to evolve its patented, cutting-edge platform into the default
for neuromodulation, increasing the accessibility for patients worldwide
while lowering the economic impact of pain management.